Comparison of Three Interventions for Antibiotic-Resistant Bacteria (ARB) Decolonization From the Gastrointestinal Tract

The aim of this research experiment is to evaluate the effectiveness of fecal microbiota transplantation (FMT) preceded by antibiotic pre-treatment versus probiotic therapy and a standard-of-care equivalent diet designed to stimulate the growth of eubiotic gut microbiota (an active comparator enhancing the ethical value of the study and increasing the chances of spontaneous decolonization of antibiotic-resistant bacteria (ARB) in the absence of any active intervention recommended by Scientific Societies) in the decolonization of bacteria with the most clinically significant antibiotic resistance mechanisms from the gastrointestinal tract of colonized patients. This study addresses the urgent need highlighted by the World Health Organization (WHO) for new strategies to combat antibiotic resistance, aiming to prevent its progression into a global pandemic that could undermine the achievements of modern civilization. Study Hypotheses: * The decolonization rate of ARB bacteria in patients undergoing the intervention (FMT or probiotic therapy) is the same as in patients treated with standard-of-care (SoC) alone. * The decolonization rate of ARB bacteria in the intervention groups (FMT or probiotic therapy) is at least 20 percentage points higher than in patients treated with the standard approach (diet). The findings from this study may contribute to developing innovative microbiota-based therapies for the decolonization of antibiotic-resistant bacteria and help reduce the global burden of antibiotic resistance.

NCT Number	NCT07094984
Lead Sponsor	Medical University of Warsaw Collaborators: Human Biome Institute S.A., Medical Research Agency, Poland
Conditions	Drug Resistance, Bacterial, Antimicrobial Drug Resistance
Enrollment	360 participants
Start Date	2024-12-31
Primary Completion	2027-02-01 (estimated)
Study Completion	2027-04-30 (estimated)
Updated on ClinicalTrials.gov	2025-09-03